Regulatory Affairs & Pharmacovigilance Officer
Milano, Italia
• Consultant for Pharmaceutical Companies: Life cycle management simultaneously; for Centralized, MRP and National products e.g. new registrations, variations, renewal, MA transfers, Line extensions, etc.• Provided regulatory guidance to internal stakeholders on product development and marketing activities.• Direct interactions with National and local Health Authorities (AIFA, Ministry of Health), and Association working groups (Farmindustria).• Reviewed and updated regulatory procedures and processes to improve efficiency and compliance.• Participated in regulatory audits and inspections to ensure adherence to quality standards.• Engage with clients to understand business challenges.• Manage contracts renewals and negotiate terms to maximize revenue and client satisfaction.• Work closely with cross-functional teams to develop competitive and profitable pricing models.• Mentoring activities for Junior members in the team. Preparation and delivery of trainings.